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Safety Alerts & Recalls

The Food and Drug Administration (FDA) has announced that new, validated manual reprocessing instructions have been issued by Olympus for the TJF-Q180V endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (duodenoscopes) after reports of multi-drug resistant bacterial infections in patients in patients who have undergone ERCP with reprocessed duodenoscopes, even when the manufacturer reprocessing instructions are correctly followed.

The FDA has issued a new safety warning regarding cases of serious and life-threatening symptomatic bradycardia as well as one case of fatal cardiac arrest following the co-administration of amiodarone with either Harvoni (ledipasvir and sofosbuvir fixed-dose combination; Gilead Sciences) or with Sovaldi (sofosbuvir; Gilead Sciences) in combination with another direct-acting antiviral (DAA).

Hospira has announced a voluntary recall of one lot of Lactated Ringer's Irrigation 3000mL following a confirmed customer report of several dark, fibrous particulate floating within the solution of the primary container.